Status:
COMPLETED
Combining Objective and Subjective Sedation Assessment Tools
Lead Sponsor:
Duke University
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedatio...
Detailed Description
Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation...
Eligibility Criteria
Inclusion
- patient in the ICU
- continuous IV sedation with propofol midazolam or dexmedetomidine
- age \> 18
- expected to require mechanical ventilation for \>=48 hours
Exclusion
- prisoners
- no available space on forehead
- continuous electroencephalography(EEG) monitoring
- bifrontal brain injury
- barbiturate coma therapy
- known hypersensitivity to study medications
- high risk for ethanol (ETOH) withdrawal
- resuscitation from cardiac arrest without recovery of mental status
- moribund clinical state (death expected within 48 hours)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00734409
Start Date
May 1 2008
End Date
July 1 2011
Last Update
March 29 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710